HOSPIRA Application 076304

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	No	No
002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-4684	Fluconazole in Dextrose	Fluconazole in Dextrose	Hospira, Inc.	ANDA	Current
0409-4684	Fluconazole in Dextrose	Fluconazole in Dextrose	Hospira, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
43069	ORIG	2007-07-06
8889	ORIG	2004-07-30